Senior Quality Assurance and Regulatory Affairs Professional
1 week ago
We are seeking a skilled Quality Assurance Specialist to support our operations in Australia and New Zealand. In this role, you will be responsible for leading day-to-day QA functions, ensuring compliance with regulatory standards, and acting as a subject matter expert on quality processes and risk assessments.
- Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
- Support compliance with ISO13485 and local regulatory standards.
- Act as the local Subject Matter Expert for quality processes and risk assessments.
- Conduct internal audits and manage CAPAs, NCs, and quality records.
- Drive validation activities for custom-manufactured products at our Sydney facility.
- Collaborate with internal teams and corporate stakeholders across the globe.
- Train and support teams on quality and regulatory matters.
- Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
Key qualifications include:
- A solid understanding of ISO 13485 and quality systems.
- Knowledge of internal auditing, CAPA, and validation processes.
- Confidence, detail-orientation, and self-motivation.
- Effective communication skills with stakeholders at all levels.
- 3+ years' experience in a QA/RA role, preferably in medical devices.
- Natural problem-solving skills and ability to thrive in a process-driven environment.
Join us in creating a high-performing, values-led QA/RA team.
-
Senior Quality Assurance
1 week ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000Quality Assurance & Regulatory Affairs AssociateWe are seeking a highly skilled professional to support and elevate our ANZ operations in quality assurance and regulatory affairs.Key Responsibilities:Lead day-to-day quality assurance and regulatory affairs functions for Australia, New Zealand, and affiliates.Support compliance with ISO 13485 and local...
-
Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000Regulatory Affairs and Quality Assurance AssociateThis role requires a seasoned professional with expertise in quality assurance and regulatory affairs.
-
Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $130,000Quality Assurance and Regulatory AffairsThis is an exciting opportunity to join our team as a Quality Assurance and Regulatory Affairs professional.Job Summary: We are seeking a highly skilled and experienced Quality Assurance and Regulatory Affairs professional to support our operations in Australia, New Zealand, and affiliates.Key Responsibilities:Lead...
-
Sydney, New South Wales, Australia Caruso's Natural Health Full timeRegulatory Affairs and Quality Assurance AssociateRegulatory Affairs and Quality Assurance AssociateGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Caruso's Natural HealthCaruso's Natural Health: A Proud Australian Family BusinessFounded in June 1982, Caruso's Natural Health is a 100% Australian-owned family...
-
Quality & Regulatory Affairs Associate
2 weeks ago
Sydney, New South Wales, Australia Buscojobs Full timeBenefitsOwnership of both QA and RA activities with strong mentoring and supportGreat opportunity for professional growth and cross-functional collaborationWork with a global pharmaceutical company committed to continuous improvementHybrid workingAbout the companyThis global pharmaceutical company offers a broad range of products across international...
-
Quality Assurance
4 days ago
Sydney, New South Wales, Australia GN Group Full timeQuality Assurance & Regulatory Affairs AssociateJoin or sign in to find your next jobJoin to apply for the Quality Assurance & Regulatory Affairs Associate role at GN GroupQuality Assurance & Regulatory Affairs AssociateJoin to apply for the Quality Assurance & Regulatory Affairs Associate role at GN GroupDo you thrive in a fast-paced environment where...
-
Quality & Regulatory Affairs Associate
2 weeks ago
Sydney, New South Wales, Australia Buscojobs Full timeBenefitsOwnership of both QA and RA activities with strong mentoring and supportGreat opportunity for professional growth and cross-functional collaborationWork with a global pharmaceutical company committed to continuous improvementHybrid workingAbout the companyThis global pharmaceutical company offers a broad range of products across international...
-
Senior Regulatory Affairs Professional
1 week ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $180,000**Senior Regulatory Affairs Specialist Position Summary**This role is focused on ensuring the quality and compliance of our medical device submissions. You will have a key impact in shaping our regulatory strategy, working closely with cross-functional teams to deliver high-quality submissions that meet global regulations.We are seeking an experienced Senior...
-
Regulatory Affairs Specialist
2 days ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $130,000Quality Assurance and Regulatory Affairs ExpertWe're seeking a highly skilled Quality Assurance and Regulatory Affairs expert to join our team.As a key member of our QA/RA function, you'll play a crucial role in ensuring compliance with regulatory standards and internal quality management systems.Lead day-to-day QA and RA activities for Australia, New...
-
Sydney, New South Wales, Australia beBeeQuality Full time $100,000 - $120,000Job Title: Quality Assurance and Regulatory Affairs Specialist">About the RoleThis role offers a unique opportunity to work within a global medical device organization, collaborating with local and global stakeholders. The successful candidate will be responsible for maintaining and implementing new process improvements to the Quality Management System (QMS)...
